A key organization says that doctors should write more prescriptions for generic drugs to hold down the high cost of medicines. That sounds reasonable. Why might this recommendation be problematic?

We are pleased to read in the Annals of Internal Medicine (online, Nov. 24, 1015) that the American College of Physicians (ACP) is paying attention to the skyrocketing cost of prescription drugs. The organization points out that we are now spending $324 billion each year on such medicines. The ACP urges its members to prescribe generic substitutes whenever possible.

The president of this organization states that “clinicians often prescribe more expensive brand-name drugs when equally effective, well-proven, and less-expensive generic versions are available.”

The group commissioned a study to see how often generic and brand-name drugs are prescribed. The patient population in the study had diabetes and was on Medicare. Between 23 and 45 percent of the prescriptions were written for brand-name medicines, even though generic versions were available. The doctor group suggests that writing prescriptions for generic drugs could help patients afford their medicines. This should make it easier for them to take their medications more consistently.

What The American College of Physicians Has Missed:

This seems like good sense and we would normally applaud the recommendations of the ACP to encourage doctors to prescribe generic drugs whenever possible. Sadly, there are some problems with this approach.

The American College of Physicians has not addressed pharmaceutical industry greed. Many of the greatest price increases seen in recent years are for new cancer drugs that are game changers for desperate patients. It is not unusual for such drugs to cost $10,000 to $15,000 per month. There are no generic substitutes for these new medications.

Important advances for treating hepatitis C can cost around $100,000 per patient. And an important new cystic fibrosis medicine can reach $259,150 per patient per year. There is no generic substitute for this medicine (Orkambi). Why isn’t the ACP tackling the issue of exorbitant pricing for orphan drugs? And by the way, some generic drugs are also skyrocketing in price (see this article for proof). Why hasn’t the ACP acknowledged this problem and argued for an end to this price gouging?

The Problem with Generic Drug Substitution:

The American College of Physicians asserts that generic drugs are just as effective as their brand name equivalents. The ACP acknowledges that there were problems with the generic antidepressant bupropion (Wellbutrin):

“…after the loss of patent protection for bupropion (Wellbutrin [GlaxoSmithKline]), dozens of spontaneous reports were submitted to the U.S. Food and Drug Administration describing a loss of antidepressant effect or new or worsening adverse effects among patients who had switched from the brand-name to the generic version of this agent. Several generic versions of bupropion were found not to be bioequivalent to the brand-name version.”

That is a gross understatement. Our website alone accounted for hundreds of reports of problems with generic bupropion (see this link). We transmitted way more than dozens of these reports to the FDA.

What About Generic Drug Manufacturing Quality?

Perhaps even more alarming than the bupropion debacle is the problem of foreign manufacture. The FDA has itself admitted that it has not had enough inspectors on the ground in countries like India and China where so many generic drugs are now made. The ACP has not acknowledged the problems with foreign-made generic drugs and the historic inability of the FDA to monitor clinical testing and manufacturing abroad.

This summer the European Union suspended the sale of 700 generic drug formulations from India. The reason was that the company responsible for testing the generic drugs in subjects in India violated standard procedures. The U.S. FDA has not identified drugs that it approved based on data generated by that company (GVK Biosciences).

Equally disturbing is a Reuters report noting that the FDA has barred 44 manufacturing plants in India from exporting their medications to the U.S. since 2011. Some of the companies involved include Aurobindo, Polydrug, Ranbaxy, Sun Pharmaceutical and Wockhardt. Check your medicine cabinet and you are likely to find a generic drug with one of those names.

Dr. Reddy and the FDA:

One of the largest Indian generic manufacturers is Dr. Reddy. Last summer the FDA required Dr. Reddy’s Laboratories to recall certain lots of the anti-seizure drug divalproex, the blood pressure pill amlodipine and the cholesterol-lowering medicine atorvastatin. On November 5, 2015, the FDA sent a Warning Letter to Dr. Reddy’s Laboratories. In that communication the FDA noted:

• significant “deviations and violations” during inspections at three pharmaceutical manufacturing facilities in India.

• There were missing entries and samples that were re-tested following failing results “until acceptable results were obtained.”

• There were “13 instances of out of specification results for a single impurity…”

• There were “manual interventions” that posed risks of “compromising sterility of the product.”

FDA’s Conclusions:

“Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes….

“Several violations are recurrent or represent long-standing failures to adequately resolve significant manufacturing quality problems. It is apparent that you have not implemented a robust quality system at your sites.”

The People’s Pharmacy Bottom Line on Generic Drug Savings:

We wish we had the same confidence in the quality of foreign-made generic drugs that the American College of Physicians seems to have. When the FDA itself uncovers such serious problems at major generic manufacturing facilities, we would think the ACP would take note.

We all want affordable, high-quality generic medicines. Here are our recommendations. We would like the ACP to adopt our suggestions and encourage Congress to pass legislation that would force the FDA to abide by these rules:

Country of origin of the active pharmaceutical ingredient (API) must be on the generic drug label. Why shouldn’t drug labels be as transparent as those on T-shirts or apples?

The FDA must release bioequivalence data for its generic drug approvals. The only way physicians, pharmacists and patients can trust the FDA’s generic drug decisions is to see the data and the bioequivalence curves. Time for transparency!

Random analysis of generic drugs for quality and performance, including dissolution properties, should become routine. Products should be sampled from pharmacy shelves across the country on a regular basis.

Authorized generic drugs made to the exact same specification as the original brand name drugs in every detail exist; consumers should be made aware which generic drugs are authorized generics and what company makes them.

We have listed our Top 10 Tips for Taking Generic Drugs in the book Top Screwups Doctors Make and How to Avoid Them. If you know someone who is taking a generic medicine, you may want to get that person a copy of Top Screwups as a holiday gift. We are offering a 20% Black Friday discount Friday, Saturday and Sunday (Nov. 27, 28 and 29, 2015). We also discuss top screwups for these common conditions: Alzheimer’s Disease, Arthritis, Back Pain, Celiac Disease, Depression, Diabetes, Fibromyalgia, Heartburn, Hypothyroidism and Osteoporosis. Here is the Black Friday code to get your 20% discount on checkout: BLKFRI20

Terri

West Virginia

January 18, 2016 at 6:56 pm

After much experience with my elderly mother and generics, which I believe have contributed to her many hospitalizations, and lingering illnesses, discussions with health care professionals have confirmed my own thoughts that these cheaply made drugs are a huge problem in why health care costs are skyrocketing and why so many people are not getting well (or sicker) when treated with these drugs.

We used to hear of this in third world nations, where the poorly manufactured drugs were sold, but now they have come to America, and the FDA is not doing their duty and the big pharma companies are getting away with their corporate greed: they pay huge fines to the government if caught, but it’s a drop in the bucket to their profits. They are not stopped from continuing to do this, so they pay the fine, and keep on manufacturing and importing. The big drug chains are in on the “scam” and the doctors most of the time have nothing to say about it: insurance companies and medicare will not pay for anything but generic, forcing consumers to have to accept the inferior generics. I get penalized by my insurance company because I cannot take one generic drug (I’ve tried) and must take the branded drug: they penalize me $200 per month, plus the cost of the drug!

I used to be a generic manufacturer in the US, and I can tell you that the FDA was on our case constantly! We had to comply with rules and regulations, manufacturing procedures, quality assurance, FDA rules, etc. and of course, we demanded topnotch QC in our own products or we would have had no business! If this had been going on in our plant, we would have been shut down without a moment’s hesitation and lost all our customers!

Consumers deserve better than this. In a nation with the best health care and doctors and facilities in the world, we are falling short in allowing this travesty to occur under our watch! There is no question that too many people are making too much money at this scheme and I am told by doctors that the FDA is now an inept and corrupt organization with its hand out.

We should be pummeling our legislators, the FDA, insurance companies and anyone else demanding that this be changed!

Terri

West Virginia

January 18, 2016 at 6:52 pm

After much experience with my elderly mother and generics, which have led to many hospitalizations and discussions with health care professionals, I believe these cheaply-made drugs are a huge factor in why health care costs are skyrocketing and why so many people are not getting well when treated with these drugs.

We used to hear of this in third world nations, where the poorly manufactured drugs were sold, but now they have come to America, and the FDA is not doing their duty, and the big pharma companies are getting away with their corporate greed: they pay huge fines to the government if caught, but it’s a drop in the bucket to their profits. They are not stopped from continuing to do this, so they pay the fine, and keep on manufacturing and importing.

The big drug chains are in on the whole scheme, and the poor doctors most of the time have nothing to say about it: insurance companies and medicare will not pay for anything but generic, forcing consumers to have to accept the inferior generics. I get penalized by my insurance company because I cannot take one generic drug (I’ve tried) and must take the branded drug: they penalize me $200 per month, plus the cost of the drug!

I believe because these drugs do not work, many people end up in hospital, or are sick much longer than they should be, and other problems are then brought on either by the lack of total cure, or by the drugs themselves causing other health issues.

I used to be a generic manufacturer in the US, and I can tell you that the FDA was on our case constantly! We had to comply with rules and regulations, manufacturing procedures, quality assurance, FDA rules, etc. and of course, we demanded topnotch QC in our own products or we would have had no business! If this had been going on in our plant, we would have been shut down without a moment’s hesitation and lost all our customers!

Consumers deserve better than this. In a nation with the best health care, doctors, and facilities in the world, we are falling short in allowing this travesty to occur under our watch! There is no question that too many people are making too much money at this scheme, and I am told by doctors that the FDA is now an inept and corrupt organization with its hand out.

We should be pummeling our legislators, the FDA, insurance companies and anyone else demanding that this be changed!

Lynn

California

January 16, 2016 at 3:40 pm

I have been on Wellbutrin since the last time you disclosed problems with the generic Wellbutrin. I have refused to take generic Wellbutrin since then. This month I had to refill my Wellbutrin with a generic made by Par, because Medicare was going to charge $580.00 for 30 pills. Is the Par generic ok or has there been problems? If there are problems I will have to fill my regular Wellbutrin.
I still have depression and I don’t want to go thru this again.
Thank you
Lynn

Cathy

November 28, 2015 at 5:23 pm

A few years ago, I was on Zetia until my insurance company wouldn’t pay for it any longer, so I was sent pravastatin. The first prescription for 3 months was manufactured by an Israeli company which I did just fine using. The second 3 month script was from a manufacturer in India, which made my nose bleed. (I have HHT and must be careful of what I ingest). I told my doctor about it and she told me to throw them away. Our meds should be made in the US!

Mark G.

Ottawa, Ontario

November 27, 2015 at 8:18 pm

Thanks for a great article about some of the many problems with generic drugs. Unfortunately, you missed another important problem with them: the fact that people in America cannot sue for damages by these drugs thanks to an unbelievably bogus decision by the Supreme Court. That’s right, the 80% or so of people taking drugs have no recourse whatsoever if they are harmed by these drugs. You can only sue if you have taken the brand name drugs, and even then it’s very hard to win against BIG PHARMA even when it is blatantly obvious that they are at fault for our problems.

I am the senior administrator in Fluoroquinolone Toxicity Group, the largest and busiest of many different facebook groups which work pretty closely together to support people who have been harmed by synthetic antibiotics like Levaquin, Cipro, Avelox and some others that have already been banned, as well as certain ear-drops and eye-drops. These are the most commonly prescribed antibiotics now, so most people have taken them, and yet very few were warned about how incredibly dangerous they are. And since the adverse drug reactions, or ADRs, usually happen weeks, months, even years after the drug was taken, the victims rarely make the connection.

This is why 99.99% of the victims have no clue about what happened and are instead misdiagnosed with fibromyalgia or ALS or Parkinson’s or chronic fatigue syndrome or Gulf War Syndrome or any of a hundred other wrong explanations for the head to toe devastation we experience. Worse yet, many patients are labeled as troublesome patients or they are considered to have psychiatric problems and forced to take more toxic drugs against their will. If any of you are suffering mysterious health problems you owe it to yourselves to google Fluoroquinolone or Levaquin or Cipro paired with toxicity or damage or problems or poison. You will be amazed at all the different groups, blogs, newscasts, books, movies, newspaper reports, magazine articles, and so on, that you will find.

This problem is so huge that there is zero chance that you do not know several people who have been affected, possibly even you. The sad thing is that if you took a generic there is no legal recourse for you because of this ridiculous law protecting BIG PHARMA instead of protecting you and me. Best wishes, everyone!

Ellen

Dallas, Texas

November 27, 2015 at 1:40 pm

I take the name brand drug for high blood pressure, Norvasc, which is a calcium channel blocker. When the generic came out, I was happy to see a lower cost. But after two days on the generic form, I awoke at 4 AM with my blood pressure ar
244/110. No more generic!

Then the generic clonidine that I take as a secondary drug for high blood pressure and which had worked so well for a long time was suddenly discontinued by my pharmacy and they put a different generic in my bottle made by a different manufacturer. That one did not work at all. And the pharmacy said they could not look for the one I had been taking because the chain that owns them would not let them do that.

I shopped all over Dallas and online before I finally found a small, independent pharmacy here that was happy to order the generic clonidine from my former manufacturer and provide it for me.

You all have written about a few generic drugs, but the truth is that they do not work well in many cases, not any of them. Today, what is called an “authorized” generic is made by the company that makes the name brand and there should not be large differences. Please comment on this. I want to know if what I am learning is correct.

November 29, 2015 at 12:43 pm

Rebecca

Arizona

November 27, 2015 at 1:36 pm

I use the brand name thyroid medication Synthroid. I have tried the generic form of Levythroxine a couple of times but it is not as effective although I have been told it is exactly the same formulation. I have frequently heard the same complaint from others users. In fact I have been told by doctors that the generic is often not as effective. I would like to know a reliable source for the generic if one exists. While not incredibility expensive (I pay about $35 mo), this is a medication taken daily by millions, mostly women, for life. Does anyone know a reliable source for the generic – Levythyroxine please?

M. Storms M.D

Marquette, MIchigan

November 27, 2015 at 1:26 pm

My husband and I believe that the US government should require all medications for use in the US be manufactured in the US under stringent guidelines. Same with vaccines and IV fluids as well as other required medical supplies. This is a public health issue of massive importance.

Helen

CA

November 27, 2015 at 11:51 am

The problem begins with the FDA. They have slapped Dr. Reddy’s, and other foreign manufacturers’, hands over and over with their silly warning letters. Those letters have no effect whatsoever. Dr. Reddy and others are still going strong raking in money. We should not be getting any drugs from any facility in India. There are horror stories online about dirty vats, cross contamination of drugs, and even traces of urine in the vats.

I don’t know what difference it makes what the doctor writes for. The brand names are just not affordable, and the pharmacy doles out the cheapest generic that they make the most profit on anyway. We don’t know if these generics are compounded to work correctly or not. The insurance plans are in cahoots with the big chain pharmacies, and you have to fight to purchase from a small independent that you can get some cooperation from. Most of them are disappearing.

Please give people the information on how to go online and check their pills by color, shape, and code to know if the pharmacist put the right pills in the bottle. Generics all look so similar, there must be hundreds of mistakes every day.

Hurrah for People's Health

November 27, 2015 at 11:44 am

I have printed your article and will send to my primary care physician who happens to be very good in my opinion. We have a co-educational relationship for which I am very grateful. I will be sending this out to many people!! Keep up your excellent (in my opinion) work!

Len

11050

November 27, 2015 at 10:19 am

Anne

November 27, 2015 at 9:28 am

And let me add that when there is no generic available, insurance has the doctor jumping thru hoops, especially if that medication has not been approved for a particular condition. I’m currently using Elidel for inflammation and hair loss on my eyebrows. I had no problem filling the prescription with one insurance carrier, but when my husband switched to another insurance, they only approved the drug for dermatitis. It took over a month of phone calls and letters to finally get it approved.

Gail

Virginia

November 27, 2015 at 8:17 am

I had a problem with generic Paxil years ago when regular Paxil went off patent. It did not seem to have any active ingredient. Switching to another generic manufacturer solved the problem, but for a long time I had to check the prescription bottle and remind the pharmacy that I would not buy that one. I submitted a report on the FDA website but got no response from them.

We invite you to share your thoughts with others, but remember that our comment section is a public forum. Please do not use your full first and last name if you want to keep details of your medical history anonymous. A first name and last initial or a pseudonym is acceptable. Advice from other commenters on this website is not a substitute for medical attention. Do not stop any medicine without checking with the prescriber. Stopping medication suddenly could result in serious harm. We expect comments to be civil in tone and language. By commenting, you agree to abide by our commenting policy and website terms & conditions. Comments that do not follow these policies will not be posted.